NCT01503047

Brief Summary

The aim of the study was to examine the effects and safety of 3 g of a 1:1 mix of c9-t11 and t10-c12 (Tonalin®) on weight control and body composition in healthy overweight individuals who maintained their normal dietary and exercise patterns.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 2, 2012

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

2 years

First QC Date

December 30, 2011

Last Update Submit

January 2, 2012

Conditions

OverweightObesity

Outcome Measures

Primary Outcomes (1)

  • body composition(DXA)

    0, 3, 6 months

Secondary Outcomes (3)

  • anthropometric parameters

    0,1, 2, 3, 4, 5 and 6 month

  • Biochemical parameters

    0, 3 and 6 month

  • HOMA-Index

    0, 3, 6 month

Study Arms (2)

CLA group

EXPERIMENTAL

Treatment consisted of exchanging the normal milk product consumed at breakfast for 200 ml of a skimmed milk with a lipid composition of 0.42 g saturated fatty acids (SFAs) and 0.72 g oleic acid, enriched with 3 g of a 1:1 mix of c9-t11 and t10-c12 (Tonalin®) (CLA group)

Dietary Supplement: Tonalin®

Placebo group

PLACEBO COMPARATOR

Treatment consisted of exchanging the normal milk product consumed at breakfast for 200 ml of a skimmed milk with a lipid composition of 0.42 g saturated fatty acids (SFAs) and 0.72 g oleic acid, enriched with 3 g oleic acid (placebo, P group.

Dietary Supplement: Placebo

Interventions

Tonalin®DIETARY_SUPPLEMENT

Treatment consisted of exchanging the normal milk product consumed at breakfast for 200 ml of a skimmed milk with a lipid composition of 0.42 g saturated fatty acids (SFAs) and 0.72 g oleic acid, enriched with 3 g of a 1:1 mix of c9-t11 and t10-c12 (Tonalin®) (CLA group)

CLA group
PlaceboDIETARY_SUPPLEMENT

Treatment consisted of exchanging the normal milk product consumed at breakfast for 200 ml of a skimmed milk with a lipid composition of 0.42 g saturated fatty acids (SFAs) and 0.72 g oleic acid, enriched with 3 g oleic acid (placebo)

Placebo group

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged 30-55 years
  • grade II overweight (BMI≥27 but \<30 kg/m2)
  • not to be adhered to any calorie restriction diet
  • not to be taking any weight control medication or have lost more than 5 kg in the three months prior to the study

You may not qualify if:

  • suffering of serious concomitant disease such as diabetes mellitus type II, metabolic syndrome (according to the criteria of the Adult Treatment Panel III), cancer, kidney disease, HIV, tuberculosis, cardiovascular disease, chronic obstructive pulmonary disease, eating disorders.
  • having undergone bariatric surgery and/or intestinal resection
  • breastfeeding and pregnancy.
  • not to give their signed, informed consent to be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Related Publications (1)

  • Lopez-Plaza B, Bermejo LM, Koester Weber T, Parra P, Serra F, Hernandez M, Palma Milla S, Gomez-Candela C. Effects of milk supplementation with conjugated linoleic acid on weight control and body composition in healthy overweight people. Nutr Hosp. 2013 Nov 1;28(6):2090-8.

    PMID: 24506387DERIVED

Related Links

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 30, 2011

First Posted

January 2, 2012

Study Start

March 1, 2008

Primary Completion

March 1, 2010

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

ES(1)